fill-it Automated GMP Cell and Strain Banking System

fill-it Automated GMP Cell and Strain Banking System

An Automated Benchtop System for Filling Screw-Cap Cryovials in GMP Laboratories fill-it decaps cryovials held in racks and then dispenses cell suspensions or other liquids before recapping. It is suitable for suspensions of mammalian, insect and microbial cells as well as other biological and non-biological liquids from bulk stocks. fill-it fits inside a standard biosafety cabinet and is ideal for automated preparation for cell banks, reference standards and other applications requiring aseptic performance and GMP compliance. fill-it creates cell banks of higher quality, consistency and viability - Maintains sample integrity by handling cells as gently but with lowered risk of contamination when compared to manual processing. - Creates higher quality cell stocks by minimizing the time cells are in contact with cryopreservative before freezing. - Increases sample consistency by filling the vials quickly, to a specified volume and tightening caps evenly to create an air lock. - Enables larger batches by mechanically creating consistent batches of 500-1000 cryovials, only one QC test is necessary per run further reducing processing cost per vial. - Improves lab productivity by reducing the possibility of human error and enabling an improved efficiency in the way lab staff work with screw-cap cryovials. - Reduces operator risk by removing the risk of injuries due to the repetitive manipulations needed to manually process large batches of screw-cap cryovials. 2

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fill-it System Combines Proven Decap Recap Modules with Aseptic Liquid Handling Single-use disposable tube sets fill-it uses a disposable, single-use, sterile tube set for all the product contact areas. Different tube set configurations are available for the three rack formats. 4-way for the 24 tube racks, V 8 way for the 48 tube racks and 8-way for the 96 tube racks. Rack transfer unit Moves the rack of screw-cap cryovials between the dispensing module and the decap recap module allowing the system to fulfill both functions in quick succession. Dispense module Automated carriage to move the racks of tubes between the decapping recapping unit and the peristaltic pump. 4

User interface Simple 3 button user interface controls all system parameters and set-up menus. Fits within biological safety cabinet System fits within standard biological safety cabinet which allows aseptic cryovial processing to take place easily and in accordance with GMP protocols. Decap recap module Removes and retains the screw-caps from the cryovials. After fiilling, recaps the vials to recommended torque setting to ensure precise sealing. Tube racks spacers Hold tubes in place at the correct height to allow processing of a range of different brands and sizes pre-racked; or loose - in dedicated 24-way stainless steel racks. 5

Functions fill-it removes all caps simultaneously and dispenses into multiple cryovials in parallel. fill-it operation The simple 3 button interface enables users to control the dispense volume and dispense speed, plus specific functions such as: - System prime and deprime - Decap dispense recap - Dispense only - Decap only or recap only (ie for manual processing offline). fill-it compatible tube types fill-it has the flexibility to work with a large range of branded screw-cap cryovials from leading suppliers such as: - Corning - Greiner - Matrix - Nalgene - Nunc fill-it accessories fill-it comes with accessories including tube racks and spacers to fit the tube types you select. Optional accessories include dispensing pots and priming tubs to further tailor it to your lab requirements. fill-it tube set Dispenses cell suspensions and liquids through a single-use sterile disposable tube set. This allows the system to transfer them aseptically form reservoir to tubes without risk of cross contamination. See fill-it Consumables, Accessories and Tube Compatibility Guide for further information including a complete list of current compatible types and sizes. 6

Applications fill-it is a valuable tool for a variety of biologics applications - Preparation of master and working cell banks for GMP applications - Preparation of reference standards monoclonal antibodies, other protein therapeutics and vaccines - Cell banks for drug discovery research assay development, screening, lead optimization, and basic research - Strain banks for biopharma process development and R&D - Strain banks for food industry, industrial biotech, and biofuels. 7

Sales and Service Contacts For further contacts, visit www.sartorius-stedim.com Europe America Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Phone +49.551.308.0 Fax +49.551.308.3289 Sartorius Stedim Systems GmbH Robert-Bosch-Strasse 5 7 34302 Guxhagen Phone +49.5665.407.0 Fax +49.5665.407.2200 France Sartorius Stedim FMT S.A.S. ZI des Paluds Avenue de Jouques CS 91051 13781 Aubagne Cedex Phone +33.442.845600 Fax +33.442.845619 Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques CS 71058 13781 Aubagne Cedex Phone +33.442.845600 Fax +33.442.846545 Austria Sartorius Stedim Austria GmbH Franzosengraben 12 1030 Vienna Phone +43.1.7965763.18 Fax +43.1.796576344 Belgium Sartorius Stedim Belgium N.V. Leuvensesteenweg, 248/B 1800 Vilvoorde Phone +32.2.756.06.80 Fax +32.2.756.06.81 Hungary Sartorius Stedim Hungária Kft. Kagyló u. 5 2092 Budakeszi Phone +36.23.457.227 Fax +36.23.457.147 Italy Sartorius Stedim Italy S.p.A. Via dell Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) Phone +39.055.63.40.41 Fax +39.055.63.40.526 Netherlands Sartorius Stedim Netherlands B.V. www.sartorius-stedim.com Phone +31.30.60.25.080 Fax +31.30.60.25.099 filtratie.nederland@sartorius-stedim.com Poland Sartorius Stedim Poland Sp. z o.o. ul. Wrzesinska 70 62-025 Kostrzyn Phone +48.61.647.38.40 Fax +48.61.879.25.04 Russian Federation LLC Sartorius ICR and LLC Biohit Uralskaya str. 4, Lit. B 199155, Saint-Petersburg Phone +7.812.327.5.327 Fax +7.812.327.5.323 Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 32 Edificio PAYMA 28108 Alcobendas (Madrid) Phone +34.902.110.935 Fax +34.91.358.96.23 Switzerland Sartorius Stedim Switzerland AG Ringstrasse 24 a 8317 Tagelswangen Phone +41.52.354.36.36 Fax +41.52.354.36.46 U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9 QQ Phone +44.1372.737159 Fax +44.1372.726171 Sartorius Stedim Biotech UK formerly TAP Biosystems York Way, Royston, Herts, SG8 5WY Phone +44.1763.227200 Fax +44.1763.227201 Ukraine LLC Biohit Post Box 440 B 01001 Kiev, Ukraine Phone +380.44.411.4918 Fax +380.50.623.3162 USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY 11716 Toll-Free +1.800.368.7178 Fax +1.631.254.4253 Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone +54.11.4721.0505 Fax +54.11.4762.2333 Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil Phone +55.11.4362.8900 Fax + 55.11.4362.8901 Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 149 Ciudad Satélite 53100, Estado de México México Phone +52.5555.62.1102 Fax +52.5555.62.2942 Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone +61.3.8762.1800 Fax +61.3.8762.1828 China Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing 101300 Phone +86.10.80426516 Fax +86.10.80426580 Sartorius Stedim Biotech (Beijing) Co. Ltd. Shanghai Branch Office 3rd Floor, North Wing, Tower 1 No. 4560 Jin Ke Road Pudong District, Shanghai 201210 Phone +86.21.68782300 Fax +86.21.68782332 68782882 Sartorius Stedim Biotech (Beijing) Co. Ltd. Guangzhou Representative Office Unit K, Building 23 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou 510070 Phone +86.20.37618687 37618651 Fax +86.20.37619051 India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq 562 123 Bangalore, India Phone +91.80.4350.5250 Fax +91.80.4350.5253 Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, 140-0001 Japan Phone +81.3.4331.4300 Fax +81.3.4331.4301 Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil 57000 Kuala Lumpur, Malaysia Phone +60.3.8996.0622 Fax +60.3.8996.0755 Singapore Sartorius Stedim Singapore Pte. Ltd. 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore 117528 Phone +65.6872.3966 Fax +65.6778.2494 South Korea Sartorius Korea Biotech Co. Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, 463-400 Phone +82.31.622.5700 Fax +82.31.622.5799 TAP Biosystems is now part of the Sartorius Stedim Biotech Group Specifications subject to change without notice. Publication No.: SBI1524-e151203 Order No.: 85037-548-43 Ver. 12 2015